Back to resultsSafety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
Primary Purpose
Carcinoma, Renal Cell
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sunitinib malate
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell
Eligibility Criteria
Inclusion Criteria: Advanced kidney cancer Exclusion Criteria: Previous treatment for kidney cancer, except surgical removal of kidney tumor
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SUNITINIB MALATE.
Arm Description
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Outcomes
Primary Outcome Measures
Number of Subjects With Overall Confirmed Objective Response (OR)
OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Secondary Outcome Measures
Duration of Response (DR)
Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7.
Time to Tumor Progression (TTP)
Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.
Progression-Free Survival (PFS)
Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.
1-Year Survival
One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.
Trough Plasma Concentrations (Ctrough) of Sunitinib
Ctrough = the concentration prior to study drug administration.
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Ctrough of SU-012662 (Sunitinib's Metabolite)
Ctrough = the concentration prior to study drug administration.
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Ctrough of Total Drug (Sunitinib + SU-012662)
Ctrough = the concentration prior to study drug administration.
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Ctrough Correlated With Serious Adverse Events (SAEs)
Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline
VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.
VEGF Ratio to Baseline at Each Time Point
VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.
sVEGFR2 Ratio to Baseline at Each Time Point
sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).
Patient-Assessed Fatigue
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.
Cancer Related Symptoms, Well-Being, and Concerns
FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00338884
Brief Title
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
Official Title
A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SUNITINIB MALATE.
Arm Type
Experimental
Arm Description
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Intervention Type
Drug
Intervention Name(s)
Sunitinib malate
Intervention Description
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Primary Outcome Measure Information:
Title
Number of Subjects With Overall Confirmed Objective Response (OR)
Description
OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Secondary Outcome Measure Information:
Title
Duration of Response (DR)
Description
Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7.
Time Frame
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause
Title
Time to Tumor Progression (TTP)
Description
Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.
Time Frame
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Title
Progression-Free Survival (PFS)
Description
Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.
Time Frame
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death
Title
1-Year Survival
Description
One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.
Time Frame
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year
Title
Trough Plasma Concentrations (Ctrough) of Sunitinib
Description
Ctrough = the concentration prior to study drug administration.
Time Frame
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Title
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib
Description
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Time Frame
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Title
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib
Description
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Time Frame
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Title
Ctrough of SU-012662 (Sunitinib's Metabolite)
Description
Ctrough = the concentration prior to study drug administration.
Time Frame
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Title
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)
Description
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Time Frame
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Title
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)
Description
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Time Frame
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Title
Ctrough of Total Drug (Sunitinib + SU-012662)
Description
Ctrough = the concentration prior to study drug administration.
Time Frame
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Title
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)
Description
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Time Frame
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Title
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)
Description
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Time Frame
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Title
Ctrough Correlated With Serious Adverse Events (SAEs)
Description
Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
Time Frame
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Title
Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline
Time Frame
Baseline
Title
VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Description
Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.
Time Frame
Baseline (Cycle 1, Day 1)
Title
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Description
Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.
Time Frame
Baseline (Cycle 1, Day 1)
Title
VEGF Ratio to Baseline at Each Time Point
Description
VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
Time Frame
Baseline to Day 1 of Weeks 3 through 53
Title
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Description
Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).
Time Frame
Baseline to Day 1 of Weeks 3 through 53
Title
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Description
Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).
Time Frame
Baseline to Day 1 of Weeks 3 through 53
Title
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Time Frame
Baseline
Title
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Description
Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.
Time Frame
Baseline (Cycle 1, Day 1)
Title
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Description
Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.
Time Frame
Baseline (Cycle 1, Day 1)
Title
sVEGFR2 Ratio to Baseline at Each Time Point
Description
sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
Time Frame
Baseline to Day 1 of Weeks 3 through 53
Title
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Description
Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).
Time Frame
Baseline to Day 1 of Weeks 3 through 53
Title
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Description
Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).
Time Frame
Baseline to Day 1 of Weeks 3 through 53
Title
Patient-Assessed Fatigue
Description
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.
Time Frame
Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
Title
Cancer Related Symptoms, Well-Being, and Concerns
Description
FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.
Time Frame
Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced kidney cancer
Exclusion Criteria:
Previous treatment for kidney cancer, except surgical removal of kidney tumor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Rosario
State/Province
Santa Fé
ZIP/Postal Code
(2000)
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Cordoba
ZIP/Postal Code
X5000AAI
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Pfizer Investigational Site
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28410911
Citation
de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
Results Reference
derived
PubMed Identifier
27238653
Citation
Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
Results Reference
derived
PubMed Identifier
25577718
Citation
Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
Results Reference
derived
PubMed Identifier
21898376
Citation
Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer. 2012 Mar 1;118(5):1252-9. doi: 10.1002/cncr.26440. Epub 2011 Sep 6.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181110&StudyName=Safety%20And%20Effectiveness%20Of%20Daily%20Dosing%20With%2037.5%20mg%20Sunitinib%20Malate%20In%20Patients%20With%20Advanced%20Kidney%20Cancer
Description
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Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
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